Europe Blog Posts

In Part Two of Emergo’s series identifying five major questions regarding Eudamed compliance under Europe’s Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR), we cover issues including roles and responsibilities of importers, distributors and Authorized Representatives, plus clinical and performance study issues.

Compliance with Eudamed database requirements under the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) may be years away, but preparation for the new requirements will take sustained effort. We've identified key issues many manufacturers are dealing with ahead of Eudamed's launch.

Swissmedic, Switzerland’s medical device market regulator, will replace its current processes for issuing export certificates as well as manufacturing certificates with an online system in order to prevent delays and free up resources.

A new version of the Manual on Borderline and Classification has been published.

The seven new positions do not contain surprises.

It appears the MDEG is not yet involved in device status or classification questions regarding the MDR or IVDR.

On April 23 2018 the European Commission published Version 1.19 of the Manual on Borderline & Classification. Following the release of Version 1.18 in December 2017 it appears the Medical Devices Expert Group (MDEG) on Borderline & Classification is quite active.

Major changes underway in the European medical device and IVD markets require manufacturers to keep up with many complex moving parts. Issues including implementation of the MDR and IVDR, ramifications of Brexit and tightening Notified Body requirements have resulted in a more challenging CE Mark certification process for many companies.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.